EpilepsyEpiCopNCT01884766
Copeptin in Childhood Epilepsy
An observational study of Epilepsy and Febrile Seizures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Epilepsy, Febrile Seizures, Children
- How many people
- 340 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children below six years presenting at the emergency unit of one tertiary university children's hospital
Who may be able to join
- All kind of seizures leading to presentation
- Age below 6 years
- Fever without seizures caused by banal infections
- Age below 6 years
Who cannot join
- No blood required for medical reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on Copeptin in Childhood Epilepsy
In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.
Read the detailed description
Background:
Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.
Working hypotheses:
- Circulating copeptin concentrations are increased after generalized seizures, including FS.
- Copeptin is predictive for complexity and relapse in FS.
Specific aims:
- to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
- to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.
- Conditions
- Epilepsy, Febrile Seizures, Children
- Medical subject headings
- Epilepsy, Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | All kind of epilepsy, including febrile seizures | |
| Control | children without seizures at presentation in the emergency but fever due to banal infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copeptin concentration in serum
Measured: at admission
Secondary outcomes (7)
base excess in blood gas analysis
Measured: at admission
prolactin
Measured: at admission
duration of seizures
Measured: at admission
Short term relapse of seizures
Measured: 24 hours after first presentation
sodium concentration
Measured: at admission
osmolality
Measured: at admission
hydrogen ion activity in blood gas analysis
hydrogen ion activity = pH
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Sven Wellmann, MD, Principal investigator, University Children's Hospital Basel, 4056 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884766
- Sponsor's protocol ID
- EKBB 352/12
- Acronym
- EpiCop
- Status last verified
- Sep 2017
- First submitted
- 10 May 2013
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stocklin B, Fouzas S, Schillinger P, Cayir S, Skendaj R, Ramser M, Weber P, Wellmann S. Copeptin as a serum biomarker of febrile seizures. PLoS One. 2015 Apr 20;10(4):e0124663. doi: 10.1371/journal.pone.0124663. eCollection 2015.
PubMed 25894585
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Copeptin in Childhood Epilepsy
- ClinicalTrials.gov ID
- NCT01884766
- Acronym / sponsor ID
- EpiCop / EKBB 352/12
- Conditions
- Epilepsy, Febrile Seizures, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.
Detailed description
Background:
Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.
Working hypotheses:
- Circulating copeptin concentrations are increased after generalized seizures, including FS.
- Copeptin is predictive for complexity and relapse in FS.
Specific aims:
- to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
- to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | – | –All kind of epilepsy, including febrile seizures |
| Control | – | –children without seizures at presentation in the emergency but fever due to banal infections |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children below six years presenting at the emergency unit of one tertiary university children's hospital
Key inclusion criteria (4 listed)
- All kind of seizures leading to presentation
- Age below 6 years
- Fever without seizures caused by banal infections
- Age below 6 years
Key exclusion criteria (1 listed)
- No blood required for medical reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Copeptin concentration in serum
Time frame: at admission
7 secondary outcomes
base excess in blood gas analysis
Time frame: at admission
prolactin
Time frame: at admission
duration of seizures
Time frame: at admission
Short term relapse of seizures
Time frame: 24 hours after first presentation
sodium concentration
Time frame: at admission
osmolality
Time frame: at admission
hydrogen ion activity in blood gas analysis
Time frame: at admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Derived from this study: PubMed 25894585Stocklin B, Fouzas S, Schillinger P, Cayir S, Skendaj R, Ramser M, Weber P, Wellmann S. Copeptin as a serum biomarker of febrile seizures. PLoS One. 2015 Apr 20;10(4):e0124663. doi: 10.1371/journal.pone.0124663. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Wellmann, MD principal investigator
University Children's Hospital Basel, 4056 Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Febrile Seizures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copeptin concentration in serum (time frame: at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.